Many applications in the field of analytical research and clinical testing utilize methods for analyzing liquid samples. Among those methods are optical measurements that measure absorbance, turbidity, fluorescence/luminescence, and optical scattering measurements. Optical laser scattering is one of the most sensitive methods, but its implementation can be very challenging, especially when analyzing biological samples in which suspended particles are relatively transparent in the medium.
One particle that often requires evaluation within a liquid is bacteria. The presence of bacteria is often checked with biological liquids, such as urine, amniotic, pleural, peritoneal and spinal liquids. In a common analytical method, culturing of the bacteria can be time-consuming and involves the use of bacterial-growth plates placed within incubators. Normally, laboratory results take may take a day or several days to determine whether the subject liquid is infected with bacteria and the type of bacteria.
Quantification of bacteria, yeast, and other organisms in fluid can be useful for medical diagnosis, drug development, industrial hygiene, food safety, and many other fields. Measurement of light scattering and absorption in samples is a known method for approximating the concentration of organisms. For example, techniques for detecting and counting bacteria are generally described in U.S. Pat. Nos. 7,961,311 and 8,339,601, both of which are commonly owned and are herein incorporated by reference in their entireties.
Accordingly, there is a need for an improved systems and methods that quickly determine whether bacteria is present in the fluid sample and determine the effect of chemoeffectors on a fluid sample. There is also a need for an improved systems and methods that more quickly determine the type of bacteria after it is determined that bacteria is present.
Regarding the data collection from medical testing, there are a wide variety of tests conducted in medical labs using collected patient specimens. These tests, performed “in vitro” can include physical, chemical, and microbiology measurements to determine patient state of health, or to advise a care path. Commonly, these tests are conducted in instruments or workstations that autonomously generate measurements and interpreted results. Results are issued by report to a proximate user in the lab (e.g., a lab operator), and may be collected by one of a variety of available general-purpose Laboratory Information Systems (“LIS”) that manage lab reporting and billing, and can be thereby be viewed by a doctor or other user at a location away from the instrument (a remote user). By this method, the lab is able to communicate the interpreted results from a variety of tests and instruments to users for any individual patient as part of the patient care record, to archive the results in a findable location indexed by the patient identity, and to record the activities for billing and other purposes.
In these installations, the central database for the LIS does not assist in the interpretation of the data, or impact the algorithms of interpretation for the instruments. In operation, a test or instrument may typically process the sample in a container or disposable which is directly marked, tagged or labeled, or otherwise uniquely affiliated with a test event identifier or Accession Number. The test data is generally retrieved from the instrument in its fully interpreted form, and is directly indexed to a unique test event identifier, such as the lab Accession Number. This record may also include patient information such as age, gender, specifics of health and care, location, and date. For some combinations and circumstances, this information could be correlated to create patient identifiable and private data, thereby requiring the LIS to be designed, operated, and maintained in such a way that such information retains its security in accordance with privacy law. Additionally, results from tests are generally indexed to a test identifier such as lab Accession Number, and recorded in the patient care record along with other private information, and therefore this data can also be considered a potentially a privacy/security concern.
There is also a need for an improved systems and methods to create a data network that can be used to collect and store medical diagnostic data in a way that is inherently immune to privacy concerns because no single database contains both the test data with any private data or collection of data which could be combined to create private data or be construed to constitute Patient Identifiable Information (“PII”). At the same time, the network includes secure software to retrieve, analyze, and correlate data from individual tests from the various databases to thus momentarily create an interpreted result, indexed to the accession identifier, and which can be delivered in digital or printed in hard copy form for the user or LIS, and which is then deleted from the system with no enduring record. In one preferred embodiment, the instruments used within the network that create data include the instruments testing for the presence and concentration of bacteria from laser scattering (or from optical instruments measuring the absorbance, turbidity, fluorescence/luminescence, and optical scattering of fluids). The data from these instruments is stored in a separate database than a database having any PII. The data may include the results of various chemoeffectors on a liquid sample containing bacteria.